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Cenerimod for Systemic Lupus Erythematosus (OPUS-1 Trial)
Phase 3
Recruiting
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 12 compared to day 1 (pre-dose baseline)
Awards & highlights
Pivotal Trial
Summary
This trial is testing cenerimod, a medication aimed at reducing symptoms of Systemic Lupus Erythematosus (SLE) in adults with moderate to severe symptoms. Researchers want to see if cenerimod can help when added to existing treatments. The medication works by calming the overactive immune system, which may reduce inflammation and other symptoms.
Who is the study for?
Adults with moderate to severe Systemic Lupus Erythematosus (SLE) who have been diagnosed at least 6 months prior and are on stable SLE medications can join. They need a certain level of disease activity and organ involvement, and women must agree to pregnancy tests and use effective contraception. Excluded are those with heart rate issues, certain heart conditions, severe respiratory diseases, liver problems, recent serious cardiovascular events or treatments that could interfere.
What is being tested?
The trial is testing Cenerimod's effectiveness in reducing SLE symptoms compared to a placebo over 12 months. It will involve around 420 participants split into two groups: one receiving Cenerimod and the other receiving a placebo pill without active medication.
What are the potential side effects?
While specific side effects for Cenerimod aren't listed here, common ones for new oral medicines may include gastrointestinal discomfort, headaches, potential liver impact or allergic reactions. The study aims to assess safety thoroughly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at month 12 compared to day 1 (pre-dose baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 12 compared to day 1 (pre-dose baseline)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) at Month 12 compared to baseline
Secondary study objectives
Response on BILAG-based Composite Lupus Assessment (BICLA) at Month 12 compared to baseline
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations (i.e., rash, alopecia, mucosal ulcers)
Side effects data
From 2017 Phase 1 & 2 trial • 105 Patients • NCT024727958%
Gastroduodenitis
8%
Nausea
8%
Arthralgia
8%
Respiratory tract infection viral
8%
Lymphopenia
8%
Laboratory test abnormal
8%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cenerimod 1 mg
Cenerimod 0.5 mg
Cenerimod 2 mg
Cenerimod 4 mg
Matching Placebo
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cenerimod 4 mgExperimental Treatment1 Intervention
Participants will receive cenerimod once daily in addition to background SLE therapy.
Group II: Matching placeboPlacebo Group1 Intervention
Participants will receive matching placebo once daily in addition to background SLE therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenerimod
2015
Completed Phase 2
~180
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Systemic Lupus Erythematosus (SLE) include immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, and azathioprine, which work by inhibiting the proliferation of immune cells and reducing inflammation. Biologic agents such as rituximab target specific components of the immune system, like B cells, to decrease autoantibody production.
Cenerimod, an S1P1 receptor modulator, works by preventing lymphocytes from exiting lymph nodes, thereby reducing their presence in the bloodstream and inflamed tissues. These mechanisms are crucial for SLE patients as they help control the hyperactive immune response, reduce organ damage, and improve quality of life.
Pharmacotherapy of lupus nephritis in children: a recommended treatment approach.
Pharmacotherapy of lupus nephritis in children: a recommended treatment approach.
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Who is running the clinical trial?
Idorsia Pharmaceuticals Ltd.Lead Sponsor
121 Previous Clinical Trials
35,533 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,221 Previous Clinical Trials
895,573 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had B cell-depleting therapy in the last year.I have severe brain-related lupus symptoms.I have not taken certain medications recently.I am not pregnant, will test monthly, and will use effective birth control during and 6 months after the study.I have not taken specific medications before screening.My lupus is affecting at least two organs moderately or one organ severely.Your doctor rates your overall disease severity as moderate to severe.My lupus is active, with significant skin or joint symptoms.I was diagnosed with lupus more than 6 months ago.I am currently on medication for lupus.I have been diagnosed with mixed connective tissue disease or similar conditions.I have a history of specific heart, lung, blood, liver, eye, or cancer-related conditions.I am taking between 7.5 and 30 mg of prednisone daily for my lupus.
Research Study Groups:
This trial has the following groups:- Group 1: Cenerimod 4 mg
- Group 2: Matching placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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